FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The proposed device Single Use Hemoclip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

AI/ML Overview

The provided text is a 510(k) summary for the "Single Use Hemoclip" device. It outlines the device's characteristics, indications for use, and comparison to predicate devices, along with performance data. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study that proves the device meets them, particularly for AI/human reader performance.

This document focuses on the substantial equivalence of a medical device (a hemoclip) to previously cleared devices based on physical and mechanical properties, not on the performance of a diagnostic AI algorithm that would typically involve acceptance criteria related to sensitivity, specificity, or human reader studies.

Here's an analysis of what information is present and what is missing from the provided text:

Information Present:

Device Name: Single Use Hemoclip
Predicate Devices: Sterile Repositionable Hemostasis Clipping Device (K152001) and SureClipTM Repositionable Hemostasis Clip (K161463).
Bench Tests Performed:
- Appearance
- Dimensional verification
- Clamping Strength Testing
- Release Force Testing
- Open and Close Mechanical Integrity of Clip Assembly
- Tensile Strength Testing
- Rotation Testing
Conclusion from Bench Tests: "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent."
Clinical Study: "No clinical study is included in this submission."
Ground Truth for Manufacturing/Bench Testing: Implied by ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7) and the specific bench tests (e.g., dimensional verification would involve measuring against design specifications).

Information Missing (and why it's missing from this specific document type):

The majority of your questions are relevant to the evaluation of a diagnostic AI device or a device where human interpretation or a specific performance metric (like accuracy, sensitivity, specificity) is key to its safety and effectiveness. This document describes a physical medical device (a hemoclip) and its physical and mechanical performance. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic algorithm are not directly applicable here.

Here's why many of your specific questions cannot be answered from this document:

Table of acceptance criteria and reported device performance (for AI): Not applicable. The "performance data" listed are for mechanical integrity and dimensions, not diagnostic accuracy.
Sample size used for the test set and data provenance (e.g. country of origin, retrospective/prospective): Not applicable for an AI test set. The "tests" were bench tests on the physical device. The relevant "sample size" would be the number of devices tested for each bench test, which is not detailed here. No patient data is involved.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical device's mechanical properties is based on engineering specifications and measurement standards, not expert reader consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size: No. Clinical studies were not conducted, and this is not a diagnostic device requiring human reader evaluation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the ground truth would be the engineering design specifications and industry standards for mechanical performance (e.g., how much force the clip should withstand, its dimensions). This is implied by the listed ISO standards.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) pertains to a physical medical device (a hemoclip) and its substantial equivalence based on bench testing of mechanical and physical properties. The framework of acceptance criteria and study design you've described (particularly questions 2-6 and 8-9) is primarily relevant to diagnostic AI/machine learning devices or clinical studies involving diagnostic accuracy or human interpretation, which are not detailed or applicable in this specific regulatory submission for this type of device.

The "acceptance criteria" for this device would be its ability to meet the specified mechanical and dimensional requirements, demonstrating equivalence to the predicate devices, as shown by the listed bench tests. The full details of these bench tests (e.g., the number of clips tested for clamping strength, the specific force values) are not provided in this summary but would be part of the full 510(k) submission.

Summary

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.